A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma
- Registration Number
- NCT04763408
- Lead Sponsor
- Eisai Inc.
- Brief Summary
The primary purpose of this study is to further characterise the hepatotoxicity in participants with advanced or unresectable hepatocellular carcinoma (HCC) treated with lenvatinib, and to further characterise the overall safety profile (serious adverse events \[SAEs\], grade 3 to 5 adverse events \[AEs\], dose modifications and discontinuations due to AEs) in participants with advanced or unresectable HCC treated with lenvatinib.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 335
- Participants with advanced or unresectable HCC for whom a decision has been made by the treating physician (at their discretion) to initiate lenvatinib or sorafenib treatment, within the prescribing conditions of the approved product label
- Participants must provide signed informed consent to participate in the study within 31 days of initiating treatment with lenvatinib or sorafenib
None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Lenvatinib Lenvatinib Participants with advanced or unresectable HCC will initiate treatment with lenvatinib capsules based on physicians decision and will be observed until withdrawal of consent, loss to follow-up, death or until the end of the study (up to 7 years) whichever occurs first. Sorafenib Sorafenib Participants with advanced or unresectable HCC will initiate treatment with sorafenib tablets based on physicians decision and will be observed until withdrawal of consent, loss to follow-up, death or until the end of the study (up to 7 years) whichever occurs first.
- Primary Outcome Measures
Name Time Method Number of Participants With Hepatotoxicity Treatment-emergent Adverse Events (TEAEs) With Lenvatinib Up to 7 years Number of Participants With SAEs With Lenvatinib Up to 7 years Number of Participants With Grade 3 to 5 AEs With Lenvatinib Up to 7 years AEs are defined as undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment with lenvatinib. AEs will be graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Here Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activity of daily living, Grade 4: life-threatening consequences; urgent intervention indicated and Grade 5: death related to AEs.
Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Lenvatinib Up to 7 years Number of participants with one or more TEAEs Leading to Dose Modifications and Treatment Discontinuations of Lenvatinib will be collected at the discretion of the treating physician and in accordance with the prescribing information.
- Secondary Outcome Measures
Name Time Method Number of Participants With Hepatotoxicity TEAEs With Sorafenib Up to 7 years Number of Participants With SAEs With Sorafenib Up to 7 years Number of Participants With Grade 3 to 5 AEs With Sorafenib Up to 7 years AEs are defined as undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment with sorafenib. AEs will be graded using NCI CTCAE. Here Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activity of daily living, Grade 4: life-threatening consequences; urgent intervention indicated and Grade 5: death related to AEs.
Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Sorafenib Up to 7 years Number of participants with one or more TEAEs Leading to Dose Modifications and Treatment Discontinuations of Sorafenib will be collected at the discretion of the treating physician and in accordance with the prescribing information.
Duration of Lenvatinib and Sorafenib Treatment Up to 7 years Number of Participants With Dose Interruption and Dose Reduction for Lenvatinib Up to 7 years Relative Dose Intensity of Lenvatinib and Sorafenib Up to 7 years Relative Dose Intensity is defined as the amount of drug administered divided by the total dose specified by the corresponding standard regimen.
Number of Participants With Dose Interruption and Dose Reduction for Sorafenib Up to 7 years Overall Survival (OS) For Lenvatinib and Sorafenib Up to 7 years OS is defined as the time from the start of lenvatinib and sorafenib treatment to date of death from any cause.
Trial Locations
- Locations (44)
California Liver Research Institute
🇺🇸Pasadena, California, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
Monash Health, Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Universitätsklinikum Innsbruck
🇦🇹Innsbruck, Tirol, Austria
Klinikum Klagenfurt Am Woerthersee
🇦🇹Klagenfurt Am Woerthersee, Austria
Universitätsklinikum St. Pölten
🇦🇹St. Pölten, Austria
Medizinische Universitat Wien (Medical University of Vienna)
🇦🇹Vienna, Austria
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